TobraDex ointment
TobraDex ointment (Tobramycin, Dexamethasone), Novartis sterile ophthalmic 3.5 gram ointment is used for inflammation, bacterial infections, and corneal injuries.
Dexamethasone is one of the most potent corticosteroids. It inhibits multiple inflammatory cytokines and produces multiple glucocorticoid and mineralocorticoid effects. Tobramycin is an antibacterial drug. It inhibits the growth of bacteria by inhibiting protein synthesis.
Topical corticosteroids are effective in acute inflammatory conditions of the conjunctiva, sclera, cornea, lids, iris, and anterior segment of the globe, as well as in ocular allergic conditions.
Package Contains: Each pack of TobraDex ointment contains 3.5 grams of ointment in an aluminium tube & a leaflet. It is also available as a TobraDex eye drop of 5ml in a dropper bottle.
Composition: Each gram contains: 
Tobramycin 3.0mg,
Dexamethasone 1.0mg.
(USP Specification)
Mfg: Novartis’s Specs
Indication: Tobradex Eye Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the bulbar conjunctiva, cornea, and anterior segment of the globe, where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.
They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
Method of Administration: Tobradex Eye Ointment: Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac(s) up to 3 or 4 times daily. It may be used adjunctively with drops at bedtime. For ocular use only. Do not let the tip of the tube touch your eye [Tobradex Eye Ointment].
Gently closing the eyelid and nasolacrimal occlusion after instillation is recommended. This may reduce the systemic absorbtion of medicinal products administered via the ocular route and result in a decrease in systemic side effects.
In case of concomitant therapy with other topical ocular medicinal products, an interval of 5 minutes should be allowed between successive applications. Eye ointments should be administered last.
Contraindications:
- Hypersensitivity to the active substances or to any of the excipients.
- Herpes simplex Keratitis.
- Vaccinia, varicella, and other viral infections of comes or conjunctiva.
- Fungal diseases of ocular structures of untreated parasitic eye infections.
- Mycobacterial ocular infections.
Undesirable Effects/ Side effects: The following adverse reactions have been reported during clinical trials with Tobradex ointment and are classified according to the subsequent convention:
- Eye disorders Uncommon: intraocular pressure increased, eye pain, eye pruritus, ocular discomfort, eye irritation Rare: keratitis, eye allergy, vision blurred, dry eye, ocular hyperaemia.
- Gastrointestinal disorders, Rare: dysgeusia.
- Immune system disorders: anaphylactic reaction, hypersensitivity.
- Nervous system disorders: dizziness, headache.
- Eye disorders: eyelid oedema, erythema of the eyelid, mydriasis, lacrimation increased.
- Gastrointestinal disorders: nausea, abdominal discomfort.
- Skin and subcutaneous tissue disorders: erythema multiforme, rash, swelling face, and pruritus.
Special Warnings & Precautions for Use: Gently closing the eyelid after instillation. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic side effects.
Sensitivity to topically may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as itching, urticarial, and skin rash.
If hypersensitivity develops during use of this medicine, treatment should be discontinued. Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral, fungal, or parasitic infections and mask the clinical signs of infection. If fungal infection occurs, corticosteroid therapy should be discontinued. Prolonged use of antibiotics such as tobramycin may result in overgrowth of non-susceptible organisms, including fungi.
If superinfection occurs, appropriate therapy should be initiated. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Contact lens wear is not recommended during treatment of an ocular inflammation or infection. In case patients are allowed to wear contact lenses, they must be instructed to remove contact lenses before application of Tobradex Eye Drops and wait at least 15 minutes before reinsertion.
Pregnancy & Lactation: Tobramycin does cross the placenta into the fetus after intravenous dosing in pregnant women. Tobramycin is not expected to cause ototoxicity from in utero exposure. Prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. The ointment is not recommended during pregnancy.
It is unknown whether tobramycin and dexamethasone are excreted in human milk following topical ocular administration. A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the benefit of therapy for the woman.
Instructions: Discard 1 month after first opening. Store at 8°-27°C. Read enclosed insert. Keep out of reach of children.
Manufactured & Buy Online: 
TobraDex ointment is manufactured by: Alcon-Couvreur NV, Belgium.
This is the link to the manufacturer: https://www.alcon.com
Sole agent: Novartis Pharma (Pakistan) Limited.
This is the link to the sole agent: https://www.novartis.com
Buy Online: https://medicalstore.com.pk
You can also buy it from any nearby pharmacy.